Qa Analyst Qualification & Validation

United Kingdom, United Kingdom

Job Description

QA Analyst - Qualification & Validation-179284

  • QA Analyst - Qualification & Validation Pirbright, Woking – (GU24) About Boehringer Ingelheim / Merial Merial is now part of Boehringer Ingelheim Animal Health. With the combined strengths of two leading players in animal health, we are now the second largest animal health business in the world. And we will use that scale and our collective resources to help make the industry even better at improving animal health. Together we can serve our customers and partners better by offering a broader range of animal health solutions. Role Purpose – QA Analyst - Qualification & Validation
    • Keep GxP systems validated/qualified properly to ensure that each piece of equipment is operating according to defined in SOPs ensuring that, before any change, the needs for qualification and validation will be evaluated
    • Ensure that the validation plan is being followed accordingly
    • Participate in technical discussions to give the QA perspective about the subject
    • Implement CAPA plan linked to the validation/qualification topics
    • Technical Documentation: assure the elaboration and maintenance of technical documentation related to qualification and validation of equipment and utilities
    • Implement guidelines and procedures for equipment validation, building a culture of validation and assure the fulfilment of the GMP validation regulation
    • Keep CAPAs on track
    • Create validation protocols and reports
    • Challenge sterile systems to ensure that they keep their sterility throughout the process
    • Approve qualification reports for HVAC and Laminar Flow Units performed by external companies
    • Execute autoclave and oven qualification
    • Perform Utilities qualification and analyse the results taken from the routine tests (trending analysis)
    • Perform IQ, OQ and PQ according to pre-approved protocols or support other areas or external companies to perform the studies
    • Execute/Support the Computerised System Validation
    • Knowledge about steam sterilisation concepts (Fo, overkill, cold point)
    • Knowledge about Clean In Place – definition of the sampling points, sampling collection, methods for analysis and specification definitions
    • Knowledge about HVAC systems for clean areas (basic knowledge and association with the validation requirements)
    • Basic quality knowledge: Change Control and Deviation management to support production areas as QA rep.
    Knowledge / Skills
    • Good communication skills and able to work with staff and external GMP inspectorates and auditors at all levels;
    • Good Leadership and management skills to embed a culture of QA throughout the site;
    • Good knowledge of the principles of EU Good Manufacturing Practice (GMP) and Quality Assurance;
    • Experience in manufacture of veterinary or human sterile products
    For more information please get in touch with Arron Parsons

Job - Manufacturing/Operations/Production
Primary Location - Europe-United Kingdom
Organization - UK-Boehringer Ingelheim Ltd
Schedule - Full-time

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Job Detail

  • Job Id
  • Industry
  • Total Positions
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
  • Job Location
    United Kingdom, United Kingdom
  • Education
    Not mentioned
  • Apply By
    Jun 06, 2018
  • Job Posting Date
    May 01, 2018